DRKS00023358
Recruiting
Phase 1
Exploring the effects of surface electrostimulation toimprove the voice quality of patients suffering fromspasmodic dysphonia and/or voice tremor
MED-EL Elektromedizinische Geräte GmbH0 sites40 target enrollmentNovember 4, 2020
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- G24.8
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
- Enrollment
- 40
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age \= 18 years
- •\- Patients diagnosed with adductory or abductory SD, and/or voice tremor, independently whether their symptoms improve upon previous Botulin injections
- •\- The effects of any previous treatments, including but not limited to Botulin injection shall be completely faded at the time of the first stimulation
- •\- Aging voice, cervical dystonia, supraglottal hyperactivity, or glottal hypoactivity do not constitute an exclusion criterion for the enrollment in this study as long as correctly and accurately described
- •\- Signed and dated informed consent before the start of any clinical investigationspecific procedure for all the recruited subjects
Exclusion Criteria
- •\- Lack of compliance with any inclusion criteria
- •\- Pregnant or breast\-feeding women
- •\- Patients for whom the previous treatment is still effective at the time of enrolment
- •\- Patients who underwent a permanent laryngeal surgery
- •\- Patients with chronic upper airway infections or severe respiratory diseases (e.g. Chronic Obstructive Pulmonary Disease (COPD) grade II or higher)
- •\- Other clinical conditions that might result in alteration of the outcomes of this clinical investigation other than those listed in the inclusion criteria
- •\- Use of an active medical implant
- •\- Known allergies or intolerance to the material used for this clinical investigation
- •\- Parallel participation in a device/drug clinical investigation in the period of data collection, which could confound the results of the clinical investigation 2020CIP004
- •\- Anything that, in the opinion of the Principal Investigator, would place the subject at increased risk or preclude the subject's full compliance with the general requirements of this clinical investigation
Outcomes
Primary Outcomes
Not specified
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